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510(k) Data Aggregation

    K Number
    K231365
    Device Name
    Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
    Manufacturer
    Anhui Intco Medical Products Co., Ltd
    Date Cleared
    2024-03-01

    (295 days)

    Product Code
    LZA, LZC, OPJ, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui Intco Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: | Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) | |-----------------------------------------|-----------------------------------------------| | Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. | | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. | | Doxorubicin Hydrichloride (2.0mg/) | >240 min. | | Etoposide (Toposar) (20.0mg/ml) | >240 min. | | Fluorouracil (50.0mg/ml) | >240 min. | | Methotrexate (25.0 mg/ml) | >240 min. | | Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. | | Thiotepa(10.0 mg/ml) | 10.1 min. | | Vincristine Sulfate(1.0 mg/ml) | >240 min. | | Cisplatin(1.0 mg/ml) | >240 min. | | Dacarbazine(10 mg/ml) | >240 min. | | Mitomycin C(0.5 mg/ml) | >240 min. | Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes. Warning: Do not use with Carmustine or Thiotepa | Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times | |-----------------------------------------|--------------------------------------| | Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
    Device Description
    The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic: - Ambidextrous with beaded cuff and straight fingers - Finger-textured, - Blue colored - Containing Hyaluronic Acid coating. - Six (6) sizes extra-small, small, medium, large, extra-large and XXL. - Tested against chemotherapy drugs and fentanyl citrate. The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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    K Number
    K233598
    Device Name
    Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs
    Manufacturer
    Anhui Intco Medical Products Co., Ltd.
    Date Cleared
    2024-01-26

    (78 days)

    Product Code
    LZA, LZC, OPJ, QDO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anhui Intco Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
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